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Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.

NCT00932295 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-12-13

No results posted yet for this study

Summary

The study's aim is to develop a clinical model that can be used to measure the nicotine delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that are marketed as a means to deliver nicotine to cigarette smokers. The study will compare the nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two devices currently marketed in the U.S.: Crown Seven and NJOY. Specifically, the effects of these devices will be compared with the effects of own brand cigarettes (positive control), and an abstinence condition (sham smoking; puffing from an unlit cigarette). The primary hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of electronic devices marketed as a means to deliver nicotine to smokers can be measured during a period of acute exposure.

Conditions

  • Smoking

Interventions

OTHER

OB

10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)

OTHER

Sham smoking

10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)

OTHER

CROWN SEVEN

10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)

OTHER

NJOY

10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Thomas Eissenberg, Ph.D. · Virginia Commonwealth University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00932295 on ClinicalTrials.gov